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Vimseltinib is a pill approved in February 2025 for tenosynovial giant cell tumour, a benign but destructive joint tumour, offering an alternative to repeated surgery.
Vimseltinib is a switch-control kinase inhibitor of CSF1R. Tenosynovial giant cell tumour is driven by CSF1 overexpression from a COL6A3-CSF1 translocation, which recruits CSF1R-positive macrophages to form the tumour mass, so blocking the receptor disperses the bulk of the lesion. Taken twice weekly, it was tested in the phase 3 MOTION trial, where the ORR at week 25 was 40% versus 0% on placebo, with improvements in range of motion, pain, stiffness and function (Lancet 2024). The FDA approved it on 14 February 2025 for symptomatic TGCT where surgery would worsen function or cause severe morbidity. No liver toxicity signal of the kind that restricted pexidartinib, the first CSF1R inhibitor, was seen; periorbital oedema was the main effect; Deciphera and Ono develop it. It is a pill for a benign but destructive joint tumour that shrinks it by dispersing the immune cells it is made of.
Switch-control inhibitor of CSF1R; TGCT is driven by CSF1 overexpression (COL6A3-CSF1 translocation) recruiting CSF1R+ macrophages.
1.Vimseltinib slips into a pocket on its target.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). FDA-approved February 2025.
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE search: vimseltinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2024-04-29 | Deciphera Pharmaceuticals (Ono) to Ono Pharmaceutical Ripretinib (Qinlock) and vimseltinib | Acquisition | not disclosed | $2.4bn | source |
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MOTION source
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Symptomatic tenosynovial giant cell tumour where surgery would worsen function or cause severe morbidity |
| EU | 2025 | Symptomatic TGCT where surgery has been exhausted or would cause unacceptable morbidity; 17 Sep 2025 |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Periorbital oedema | 45% | - |
| Fatigue | 33% | - |
| Increased CPK | 28% | - |
| Pruritus | 28% | - |
MOTION. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Vimseltinib" OR ABSTRACT:"Vimseltinib" OR TITLE:"Romvimza" OR ABSTRACT:"Romvimza") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Vimseltinib, not a curated reading list.
Shares CSF1, CSF1R, Tenosynovial giant cell tumour (TGCT), Myeloid suppression: TAMs, MDSCs & don't-eat-me signals.
Shares CSF1R, Tenosynovial giant cell tumour (TGCT), Sarcomas (soft tissue, bone, GIST), Small-molecule kinase inhibitors.
Shares CSF1, CSF1R, Small-molecule kinase inhibitors.
Shares Deciphera Pharmaceuticals (Ono), Sarcomas (soft tissue, bone, GIST), Small-molecule kinase inhibitors.
Shares Tenosynovial giant cell tumour (TGCT), Small-molecule kinase inhibitors.
Shares Deciphera Pharmaceuticals (Ono), Small-molecule kinase inhibitors.